Synopsis

Silicone breast implants (SBI) are widely used in women both for medical and cosmetic reasons. During the last decade there has been much debate whether the use of SBI is related to health complaints. Recently a laboratory assay has been described, designated the APA-assay ( Anti-Polymer Antibody), which detects antibodies directed to a polymer in serum of patients with SBI (Tenenbaum et al, 1997). The level of antipolymer antibodies was described to be associated to the severity of the clinical symptoms of SBI recipients. The report describes the introduction and performance of the APA-assay at the RIVM. The results obtained at the RIVM were compared to the results obtained by Autoimmune Technologies LLC, (New Orleans, USA) (manufacturer and patent holder of the assay). Reference and test samples were provided by Autoimmune Technologies LCC. Substitution of the chemicals supplied by Autoimmune Technologies, by chemicals obtained from local suppliers had no impact, simmilar results were observed using both sets of chemicals. In conclusion, the APA-assay was successfully introduced in our laboratory. Intra-assay variability and inter-assay variability were found to be within an acceptable range. Hence, the APA-assay gives reproducible results, and can be used for the evaluation of the presence of antipolymer antibodies in serum of women with a silicone breast implant.